BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1994166 · Received February 16, 2011

    Report

    Report Number
    2024168-2011-00938
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE DEVICE WAS FULLY CLIP DEPLOYED. THE SHEATH HAD BEEN FULLY SLIT WITH NO DAMAGE DETECTED INDICATING THAT IS WAS NOT A CONTRIBUTING FACTOR IN THE EVENT. THE THUMB ADVANCER WAS RETRACTED FROM THE FINISH POSITION. THE CLIP WAS FOUND AT THE DISTAL END OF THE FLEX TUBE. THE MOST PROBABLE CAUSE FOR THE MISLOCATED CLIP IS LIKELY A COMBINATION OF THE INABILITY OF THE VESSEL LOCATOR TO RETRACT PROPERLY AND ANATOMICAL ISSUES PREVENTING THE PROPER EJECTION OF THE CLIP OFF THE DISTAL END OF THE DEVICE. THE DEVICE WAS DISASSEMBLED AND THERE WERE NO ABNORMAL OBSERVATIONS FOUND. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. THERE WERE NO SIMILAR COMPLAINTS WITHIN THIS LOT FOR THE CLIP/DISTAL END OF DEVICE FAILURE MODE AT THE TIME OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING CLIP DEPLOYMENT, THE WINGS DID NOT RETRACT AND THE CLIP WAS CAUGHT IN THE WINGS. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 950256H

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention